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    Summary
    EudraCT Number:2013-001695-38
    Sponsor's Protocol Code Number:D1050301
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-01-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-001695-38
    A.3Full title of the trial
    A 6-Week Randomised, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lurasidone for the treatment of schizophrenia in paediatric patients
    A.4.1Sponsor's protocol code numberD1050301
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/145/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSunovion Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSunovion Pharmaceuticals Inc.
    B.5.2Functional name of contact pointRobert Goldman
    B.5.3 Address:
    B.5.3.1Street AddressOne Bridge Plaza, Suite 510
    B.5.3.2Town/ cityFort Lee, NJ
    B.5.3.3Post code07024
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012012288319
    B.5.5Fax number0012015925939
    B.5.6E-mailrobert.goldman@sunovion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lurasidone
    D.2.1.1.2Name of the Marketing Authorisation holderSunovion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLurasidone
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    schizophrenia
    E.1.1.1Medical condition in easily understood language
    schizophreniad
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10001064
    E.1.2Term Acute schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    E.2.2Secondary objectives of the trial
    *Change from Baseline in Clinical Global Impression severity (CGI-S) scale score, CDRS-R score, PQ-LES-Q score, Children’s Global Assessment Scale (CGAS) score, and PANSS positive, negative, general psychopathology, cognition score and excitability subscale scores, as compared to placebo
    *Proportion of responders where response is based on 20 percent or greater improvement from baseline in PANSS total score at the last observed value
    *Proportion of patients achieving remission defined as a score not exceeding 3 (mild severity) for items P1, P2, P3, N1, N6, G5 and G9 of the PANSS
    *discontinuation due to AEs, SAEs; frequency and severity of suicidality laboratory parameters , vital signs, physical examinations and ECGs, mean change from for height and body weight, mean changes of BMI and waist circumference, UKU, and cognitive side effects, Tanner staging, hormonal parameters, Movement disorders, suicidality (C-SSRS), patients who discontinued due to AEs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Subjects must provide written informed assent and be willing to participate in the study.
    Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
    2. Male or female subjects 13 to 17 years of age, inclusive.
    3. DSM-IV-TR axis I primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes) and confirmation of the schizophrenia diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL).
    4. In the judgment of the clinician, the subject has an acute exacerbation of psychotic symptoms (no longer than 2 months in duration) and marked deterioration of function from baseline (by history), or, the subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening
    5. Willing and able to adhere to protocol-specified meal requirements during dosing.
    6. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
    E.4Principal exclusion criteria
    1. Has a history or current diagnosis of mental retardation neurological malignant syndrome or any neurologic disorder or severe head trauma.
    2. Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood– eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders.In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure of alcohol withdrawal seizure is not exclusionary
    3. A history of electroconvulsive therapy (ECT).
    4. Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
    5. Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
    E.5 End points
    E.5.1Primary end point(s)
    evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 Weeks
    E.5.2Secondary end point(s)
    •Change from Baseline in Clinical Global Impression severity (CGI-S) scale score, as compared to placebo
    •Change from Baseline in PANSS positive, negative, general psychopathology, cognition score and excitability subscale scores
    •CDRS-R score
    •Proportion of responders where response is based on 20 percent or greater improvement from baseline in PANSS total score at the last observed value
    •PQ-LES-Q score
    •Children’s Global Assessment Scale (CGAS) score
    •Proportion of patients achieving remission defined as a score not exceeding 3 (mild severity) for items P1, P2, P3, N1, N6, G5 and G9 of the PANSS
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 Weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Bulgaria
    China
    Italy
    Romania
    Colombia
    Korea, Democratic People's Republic of
    Malaysia
    Puerto Rico
    Spain
    Mexico
    Philippines
    Serbia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 249
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 249
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 249
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Sunovion Pharmaceuticals Inc.
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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